Expired Study
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Nashville, Tennessee 37215


Purpose:

The purpose of this research is to compare the safety and effectiveness of three different concentrations (amount of study drug in a liquid preparation) of an investigational drug (sodium deoxycholate for injection) solution against a placebo (a solution that looks similar but does not have any active drug in it) in the treatment of superficial lipomas.


Study summary:

The purpose of this research is to compare the safety and effectiveness of three different concentrations (amount of study drug in a liquid preparation) of an investigational drug (sodium deoxycholate for injection) solution against a placebo (a solution that looks similar but does not have any active drug in it) in the treatment of superficial lipomas. Sodium deoxycholate for injection is a chemical similar to the one produced by the body. A lipoma is a fatty lump typically located on the trunk, shoulder, arms and legs. For the purposes of this study, only lipomas on the trunk, arms, legs or neck will be treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles or feet will not be treated.)


Criteria:

Inclusion Criteria: - One or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least two perpendicular diameters, and have the following characteristics: - History of slow growth followed by dormancy, and stable for at least six months. - Greatest length by greatest perpendicular width between 1 and 16 square centimeters - Discrete, oval tor rounded in shape, not hard or attached to underlying tissue. - Located on the trunk, arms, legs, or neck. - Signed informed consent. Exclusion Criteria: - Absence of significant medical conditions that could affect safety. - History of treatment for lipomas. - Treatment with an investigational agent within 30 days before ATX-101 treatment.


Study is Available At:


Original ID:

ATX-101-07-05


NCT ID:

NCT00608842


Secondary ID:


Study Acronym:


Brief Title:

Phase 2 Study for the Treatment of Superficial Lipomas


Official Title:

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Kythera Biopharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

62


Enrollment Type:

Actual


Overall Contact Information

Official Name:Patricia S. Walker, M.D., Ph.D.
Study Director
Kythera Biopharmaceuticals, Inc.

Study Dates

Start Date:November 2007
Completion Date:October 2008
Completion Type:Actual
Primary Completion Date:August 2008
Primary Completion Type:Actual
Verification Date:May 2014
Last Changed Date:May 28, 2014
First Received Date:January 23, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Lipoma size reduction
Time Frame:24 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety assessments with Laboratory tests
Time Frame:24 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety assessments with ECG
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety assessments with Medical Evaluations
Time Frame:24 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:ATX-101
Arm Name:ATX-101 (1mg/cm2)
Other Name:sodium deoxycholate
Intervention Type:Drug
Name:placebo
Arm Name:placebo

Study Arms

Study Arm Type:Experimental
Arm Name:ATX-101 (1mg/cm2)
Study Arm Type:Experimental
Arm Name:ATX-101 (4 mg/cm2)
Study Arm Type:Experimental
Arm Name:ATX-101 (8 mg/cm2)
Study Arm Type:Placebo Comparator
Arm Name:placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Kythera Biopharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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